Registration Dossier
Registration Dossier
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EC number: 464-520-3 | CAS number: 189813-45-4
Endpoint summary
Administrative data
Description of key information
The test substance is classified as R36 and Cat 2A according to EU and GHS standards, respectively.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation:
In the key study (BASF AG, 2000) performed according to OECD guideline 404 (Acute dermal irritation / Corrosion) and GLP, acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 0.3 for erythema and 0.0 for edema. The skin findings were reversible in all animals within 72 hours after removal of the patches; thus the study was terminated. Based on the results, the test substance does not give indication of an irritant property to the skin.
Eye Irritation:
In the key study (BASF AG, 2000) performed according to OECD guideline 405 (Acute Eye irritation / Corrosion) and GLP, damage to the conjunctiva, iris or cornea was assessed in 3 Himalayan rabbits, subjected to a single ocular application of 0.1 ml bulk volume (about 43 mg) of the test substance. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.9 for conjunctival redness and 2.1 for chemosis. The findings were reversible in all animals within 21 days after application; thus the study was terminated. Based on the results, the test substance gives indication of an irritant property to the eye, and classified as R36 and Cat 2A according to EU and GHS standards, respectively.
Effects on eye irritation: irritating
Justification for classification or non-classification
EU classification according to Annex VI of Directive 67/548/EEC: Xi; R36
EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008: Cat 2A
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